BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1053200 · Received May 28, 2008

    Report

    Report Number
    1056600-2008-00177
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 25, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE DETERMINED. AN OCD FIELD ENGINEER VISITED THE SITE AND REPLACED THE PROBE AND THE WASH STATION. HOWEVER, QUALITY CONTROL TESTING WAS STILL NEGATIVE. THE CUSTOMER PERFORMED TESTING USING A NEW QC SAMPLE AND OBTAINED POSITIVE RESULTS. INSTRUMENT WAS PERFORMING AS EXPECTED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER RESULTED A POSITIVE DAT SAMPLE AS NEGATIVE DURING QC TESTING. THE CUSTOMER VISUALLY CONFIRMED THE PROCESSED GEL CARDS TO BE NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED. INCIDENT APPEARS TO HAVE OCCURRED INDEPENDENT OF TEST METHOD. IF THE EVENT WERE TO RECUR WITH BLOOD GROUPING AND/OR ANTIBODY SCREENING TESTS, IT CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST. KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1